MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY PUMP; PUMP, INFUSION

Model Number 6400

Device Problems Failure to Power Up (1476); Priming Problem (4040)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2022

Event Type  malfunction  

Event Description

Indication: secondary pulmonary arterial hypertension.Unsolicited communication: pt reports she is having issues with both of her cadd legacy pumps (serials: (b)(4) and (b)(4)).On (b)(6) 2022, pt said the pump was alarmed at 4:30 am with high pressure alarm.Pt said she checked her tubing and did not any blockages for kinks.Pt said she shut pump off and then pump would not restart.Pt mixed new cassette and placed it in back-up pump.Process took her about 1.5 hours (pt without infused medication for this time.) pt said she was able to continue infusion with backup and new cassette.On (b)(6) 2022 pt said pump she was wearing alarmed with no disposable, pump won't run.Pt said she made new cassette and used the pump that alarmed from (b)(6) 2022.Pt had a hard time priming but she was able to and continues infusing.Advised pt that alarm for no disposable likely due to bad cassette and not pump.Lot number for second cassette: 4271469, advised pt will send two new pumps.Photographs were not provided.Setflow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.This is a continuous infusion.Pump return tracking info is not available.No add'l info is available at this time.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? yes; did we [mfr] replace the cassette? no, pt says she has enough cassettes at home.Did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.Other: "04/19/2023." reported to cvs/caremark by pt/caregiver.

• Brand Name: CADD LEGACY PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 15163561
• MDR Text Key: 297350180
• Report Number: MW5111266
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2022
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female